Question & AnswerQ&A (BFAD FDA REGULATION NO. 001-C s. 1982)
The regulation applies to infant food in powdered form (infant formula) intended as a substitute for human milk to meet the normal nutritional requirements of infants.
Infant formula is defined as a product based on milk of cow or other animals (including fish) or plant origin, suitable for infant feeding.
An infant is defined as a person not more than 12 months of age.
Infant formula products must prominently indicate a "Best before" date on their label or package.
It indicates the date at which specified limits such as maximum moisture content, maximum Vitamin C content, and minimum percent solubility are expected to be reached.
The maximum moisture content allowed is 3.5%.
Vitamin C content must be at maximum 90% of the label claim but not lower than 30 mg per 100 mg of sample.
The minimum percent solubility required is 80%.
Full compliance became effective in January 1983.
The regulation was adopted by Catalina C. Sanchez, Acting Administrator, and J. C. Azurin, Minister of Health.